Preservative Efficacy (Challenge) Test

Preservative Efficacy (Challenge) Test

€ 180.00

Preservative Efficacy (Challenge) Test

Preservative Efficacy (Challenge) Testing verifies that cosmetic preservatives effectively control microbial growth, ensuring EU regulatory compliance and consumer safety.

 

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Description

The Preservative Efficacy Test (PET), also called the Challenge Test, is a key requirement in cosmetic product safety assessment under EU Cosmetic Regulation (EC) No 1223/2009. It verifies that the preservatives in your formulation effectively control microbial contamination during the product’s shelf life and use period.

Cosmetic products can encounter microorganisms during manufacturing, storage, transportation, and consumer use. Therefore, the Challenge Test evaluates whether your preservative system inhibits the growth of pathogenic and non-pathogenic microorganisms, protecting consumer health and ensuring product integrity.

Regulatory Importance and EU Compliance

EU regulations mandate evidence of microbiological safety for all cosmetic products. Challenge Test results must appear in the Product Information File (PIF) and support the Cosmetic Product Safety Report (CPSR).

Moreover, these results demonstrate that your product is microbiologically stable, safe under normal and foreseeable conditions, and compliant with EU market access rules. Without sufficient preservative efficacy data, products may face non-compliance, delayed market entry, or regulatory action.

Testing Standards and Methodology

We conduct Preservative Efficacy Tests according to ISO 11930:2019 and other international standards. The process involves:

  • Inoculating your product with specific strains of bacteria, yeasts, and molds
  • Monitoring microbial reduction over defined time intervals
  • Assessing whether your preservative system meets EU acceptance criteria

This method ensures reliable and regulator-accepted results.

Accredited Laboratories and Professional Support

We collaborate with fully accredited, EU-recognized laboratories. This guarantees that all testing meets high scientific and regulatory standards.

Additionally, our regulatory team guides you on:

  • Sample selection and preparation
  • Packaging and shipping requirements
  • Documentation needed for PIF inclusion

This approach minimizes testing delays and ensures accurate, reproducible outcomes.

Why Preservative Efficacy Testing Matters

  • Confirms the effectiveness of your preservative system
  • Supports CPSR and PIF compliance
  • Reduces microbiological risk to consumers
  • Demonstrates due diligence under EU law
  • Facilitates smooth and compliant EU market entry

By performing robust Preservative Efficacy Testing, cosmetic brands can confidently demonstrate product safety, regulatory compliance, and commitment to consumer protection across the EU.

Additional information

How much sample is required for the challenge test?

The minimum amount required is 200 g or 200 ml, ideally in the original packaging to reflect real product conditions.
How should I prepare my samples?

Samples should be sealed and clean, preferably in the original packaging. Handle carefully to avoid contamination before shipment to the lab.
Where should I send the samples?

Samples are shipped directly to our partner laboratories in Istanbul/Türkiye. The labs are fully accredited and operate according to EU standards. After purchase, our team will provide the exact lab and shipping address based on the type of test.
How long does the challenge test take?

The test usually takes 40–45 days after the samples arrive at the laboratory.
Why test in Türkiye?

Our Türkiye-based labs offer a cost-effective solution without compromising quality. They provide accurate, reliable, and EU-compliant results, with state-of-the-art equipment and experienced staff, making them a smart choice for small and medium cosmetic manufacturers.
Are any products exHow can I tell if my product is exempt from the challenge test?empt from the challenge test?

Some cosmetic products may not require a preservative efficacy (challenge) test, depending on their formulation and microbial risk. Common exemptions include: Completely anhydrous products (contain no water) or those with very low water activity. Single-use or contamination-proof packaging, such as sealed ampoules or sachets. Alcohol-based products with sufficiently high antimicrobial content. Even if your product may qualify for an exemption, microbiological testing is still recommended to confirm its initial microbial quality and support your Product Information File (PIF). Any exemptions and the rationale should be documented in the CPSR, in accordance with Annex I, Part B of Regulation (EC) No 1223/2009.

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